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Fluticasone propionate

Phase 3

Seasonal Allergic Rhinitis | Small molecule | Other |AstraZeneca PLC|Last Updated: Jan 24, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment750
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00641680Rhinocort Aqua Versus Placebo and Fluticasone PropionatePHASE3 COMPLETED 750Apr 1, 2003Jul 1, 2003Jan 24, 2011 -
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Study Endpoints
Primary Endpoints
To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.
2 weeks
Secondary Endpoints
To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
2 weeks
To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
2 weeks
Safety assessment via adverse events and clinical measurements.
2 & 4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALBudesonide
2ACTIVE_COMPARATORFluticasone propionate
3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BudesonideDRUG -
Fluticasone propionateDRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * At least a 2 year documented history of seasonal allergic rhinitis * who, in the opinion of the investigator, * is a candidate for treatment with nasal steroids based on a history of either * a)inadequate control of symptoms with antihistamines, decongestants and/or immunot...

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